# K231267: ClearTip

- Pathway: 510(k) (Traditional)
- Applicant: Finemedix Co., Ltd.
- Decided: Jun 30, 2023 after 59 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894632 (1989). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 63 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133763: Sonotip Pro and Pro Flex Ebus-Tbna Needle System, Medi-Globe Corporation (2014) Summary page 4.

## Most influential descendants
- K250994: ClearTip FNA and FNB Types (2025), 0 descendants of its own

## Indications for use
The ClearTip is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

Source page: https://510kreport.com/device/K231267
Methodology: https://510kreport.com/methodology